Focusing on complex generics
Even though there are clearly defined guidelines on biowaivers, Indian companies are facing challenges in achieving the desired results. The main challenges for these include achieving biowaivers for complex generics and modified release products, interpretation of dissolution tests, lack of success stories for reference, stringent review process, characterization and identifying expectations of regulatory authorities.
Based on these challenges and the immense potential that lies in approvals of these specific products, Treffen media brings you a comprehensive two-day workshop with former USFDA Director and MHRA senior assessor who have been a part of the drafting committee of some of these guidelines. Our experts will bring you drug specific case studies and clarify the regulatory authorities’ perspective and expectations to help you secure faster and hassle free approvals.
- Former USFDA and MHRA trainers
- Case studies on each perspective
- Dissolution tests and interpretation as per regulatory norms
- One on one QnA opportunity
- Special focus on complex generics and modified release products
- Guidance on orphan drugs and highly variable drugs
Who should attend
Biowaivers and Bioequivalence workshop is a comprehensive platform for all teams working in pharma and bio-pharma companies working on complex and non complex drug products. The agenda has been specially designed for professionals who are facing challenges in submissions and achieving biowaivers for their immediate release and modified release drug products.
Scientists, Managers, Directors and Heads working in:
Our USFDA and MHRA experts will update you on the rationale behind the guidance and the latest regulatory updates and expectations of the region specific regulators.
Research and development
Specific case studies covering complex generics in both solid oral dosage forms and other delivery modes will help you get practical solutions to your drug delivery challenges.
Techniques and challenges associated with analytical development while conducting dissolution testing and stability testing. Critical review of each of the technique in accordance with regulatory expectation.
Biowaivers, BA/BE studies and IVIVC correlation are an important performance indicators to assure batch to batch quality and define process validation.
Dr. Mansoor A. Khan
Former Director, Division of Product Quality Research and SBRS Scientist, CDER, FDA and Professor and Vice Dean, Presidential Impact Fellow, Texas A&M University, Rangel College of Pharmacy
Dr. Mansoor A. Khan served for over 11 years as the Director of Product Quality Research and a Senior Biomedical Research Scientist (SBRS) at CDER in US FDA where he led research teams on biotech products and small molecules, chemistry and stability, drug delivery systems and bioavailability/bioequivalence, and chemistry review teams of new and generic drugs for several complicated products.
He has received FDA/CDER 2015 outstanding ANDA reviews award, over ten FDA/CDER Team Excellence Awards, FDA/CDER Scientific Achievement Award, and FDA/CDER Exemplary Performance Awards, outstanding alumni award from St. Johns University, College of Phamacy, Excellence Award from Texas A&M.
He is a registered pharmacist, and earned his Ph.D. degree in Industrial Pharmacy from the St. John’s University School of Pharmacy in 1992. He has published over 275 peer-reviewed manuscripts, five texts including “Pharmaceutical and Clinical Calculations” and “Quality by Design for Biopharmaceutical Drug Product Development, 25 book chapters, 250 poster presentations, and more than 250 invited presentations world-wide. Dr. Khan’s research focus is primarily in the area of formulations design and development, and biopharmaceutics. He led the FDA new drug review team that approved the first 3D product on Aug 3, 2015
Dr Muhaned Al-Hindawi
Former Senior Pharmaceutical Assessor, MHRA and Managing Director and Principal Consultant, Ontarget Pharma Consultancy
Dr Muhaned is currently the managing director and principal consultant of “Ontargetpharma Consultancy”, London UK prior to that he worked as a Senior Pharmaceutical Assessor with MHRA for more than 10 years. During his tenure at MHRA, he made several break-through issues affecting the common understanding by the agency and applicants. To mention a few –
- The dissolution performance of multiple- strengths of oral solid dosage forms and how biowaiver can be applied
- Effect of excipient on the bioavailability of API from aqueous oral solution and biowaiver criteria
- Technical and quality standards of Vitamin D3 as API and finished product.
Prior to joining MHRA he occupied many technical posts in the pharmaceutical industry with over 20 years of hand on experience in new product development, construction of method of analysis with special interest in HPLC, Stability & kinetics, as well as in technology transfer, and process validation.
He holds a Ph.D. degree from UK, University of Wales, Cardiff, “Effect of Solvent on the Bioavailability of Testosterone Propionate from Oily Injections” and is also a member of the Royal Pharmaceutical Society of GB, pharmaceutical society of NZ and a registered pharmacist in UK.
Dr. Ajaz Hussain
President, NIPTE and Principal, Insight Advice & Solutions LLC
Ajaz is a globally recognised leader in pharmaceutical quality and is one of the most influential‘Medicine Maker’ (named in the 100 Power list by the UK’s Medicine Maker magazine in 2015). He trained at the Bombay College of Pharmacy (B. Pharm, 1981) and received an interdisciplinary doctoral degree from University of Cincinnati (1986). He began his career as Assistant Professor of Pharmacy at the Ohio Northern University and in 1989 he returned to University of Cincinnati as Research Assistant Professor of Pharmaceutics. He was promoted to Associate Professor (1992) and achieved tenure status in 1994. In 1995 he moved to the US FDA CDER as Branch Chief for Biopharmaceutics Research and thereafter was rapidly promoted with increasing oversight and policy development responsibilities in the area of product quality (Director Product Quality Research (DPQR) and then Director Office of Testing and Research). In 2000 he was promoted to the position of Deputy Director Office of Pharmaceutical Science and served under the Senior Biomedical Research Service (SBRS – a track under the Public Health Service Act). His contributions at FDA range from research on specific topics (such as the Biopharmaceutics Classification System Guidance) to global policy development (such as ICH Q8) in the area of Quality by Design. He launched and led the FDA’s PAT Initiative. He and his teams were recognized by two FDA Scientific Achievement Awards. In 2005 he moved to Sandoz (a division of Novartis Corp.) as Vice President and Global Head for Biopharmaceutical Development and contributed to this organization for achieving the industry leadership position in Biosimilars. He was then recruited by Philip Morris International (PMI) in Switzerland to develop adjacent business opportunities (tobacco plant-based vaccines) and to establish a rigorous scientific basis for tobacco harm reduction. At PMI he was promoted to the position of Chief Scientific Officer. For about a year he served as the Chief Scientific Officer and President Biotechnology at Wockhardt Ltd. He launched his consulting firm Insight Advice and Solutions LLC in July 2013. In October 2014, he was also appointed as the Executive Director of the National Institute for Pharmaceutical Technology and Education, a collaboration among pharmaceutical science and engineering programs at 17 major universities in the USA. He was elected President of NIPTE in February 2016. Ajaz is a Fellow of the American Association of Pharmaceutical Scientist and of the Swiss Society of Pharmaceutical Sciences.
Radisson Blu Plaza Hotel Hyderabad Banjara Hills
8-2-409, Road Number 6, Banjara Hills, Hyderabad, Telangana 500034
Radisson Blu Plaza Hotel Hyderabad Banjara Hills8-2-409, Road Number 6, Banjara Hills, Hyderabad, Telangana 500034
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